Statement of Principles concerning steatohepatitis (Reasonable Hypothesis) (No. 86 of 2022) (Cth)

Case

Statement of Principles

concerning

STEATOHEPATITIS
(Reasonable Hypothesis)

(No. 86 of 2022)

The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated   23 August 2022.

The Common Seal of the
Repatriation Medical Authority
was affixed to this instrument
at the direction of:

Professor Terence Campbell AM
Chairperson

Contents

1Name........................................................................................................................................... 3

2Commencement........................................................................................................................ 3

3Authority..................................................................................................................................... 3

4Repeal......................................................................................................................................... 3

5Application................................................................................................................................. 3

6Schedules.................................................................................................................................... 3

7Kind of injury, disease or death to which this Statement of Principles relates............... 3

8Basis for determining the factors........................................................................................... 4

9Factors that must exist............................................................................................................. 4

10Relationship to service............................................................................................................. 5

11Factors referring to an injury or disease covered by another Statement of Principles. 5

Schedule 1 - Dictionary............................................................................................. 6

1Definitions.................................................................................................................................. 6

Schedule 2 - Drugs..................................................................................................... 8

1Specified drugs........................................................................................................................... 8

  1. Name

This is the Statement of Principles concerning steatohepatitis

(Reasonable Hypothesis) (No. 86 of 2022).

  1. Commencement

This instrument commences on 19 September 2022.

  1. Authority

This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986.

  1. Repeal

The Statement of Principles concerning steatohepatitis No. 79 of 2013 (Federal Register of Legislation No. F2013L01898) made under subsection 196B(2) of the VEA is repealed.

  1. Application

This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies.

  1. Schedules

Any item in a Schedule to this Instrument has effect according to its terms.

  1. Kind of injury, disease or death to which this Statement of Principles relates

(1)This Statement of Principles is about steatohepatitis and death from steatohepatitis.

Meaning of steatohepatitis

(2)For the purposes of this Statement of Principles, steatohepatitis:

(a)means the presence of fatty change and inflammation of the liver with hepatocyte injury, with or without fibrosis; and

(b)includes alcoholic steatohepatitis and non-alcoholic steatohepatitis; and

(c)excludes:

(i)alpha-1 antitrypsin deficiency;

(ii)biliary obstruction;

(iii)haemochromatosis; and

(iv)Wilson's disease.

Death from steatohepatitis

(3)For the purposes of this Statement of Principles, steatohepatitis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's steatohepatitis.

Note: terminal event is defined in the Schedule 1 – Dictionary.

  1. Basis for determining the factors

The Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that steatohepatitis and death from steatohepatitis can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the MRCA.

Note: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.

  1. Factors that must exist

At least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting steatohepatitis or death from steatohepatitis with the circumstances of a person's relevant service:

(1)having hypertension before the clinical onset of steatohepatitis;

(2)having diabetes mellitus at the time of the clinical onset of steatohepatitis;

(3)being obese at the time of the clinical onset of steatohepatitis;

Note: being obese is defined in the Schedule 1 – Dictionary.

(4)having rapid weight loss causing protein-calorie malnutrition within the 18 months before the clinical onset of steatohepatitis;

Note: rapid weight loss is defined in the Schedule 1 – Dictionary.

(5)undergoing jejunoileal bypass surgery before the clinical onset of steatohepatitis;

(6)receiving total parenteral nutrition for at least 3 months within the 1 year before the clinical onset of steatohepatitis;

Note: total parenteral nutrition is defined in the Schedule 1 – Dictionary.

(7)having dyslipidaemia at the time of the clinical onset of steatohepatitis;

Note: dyslipidaemia is defined in the Schedule 1 – Dictionary.

(8)for males, consuming at least 55 kilograms of alcohol within any 5 year period before the clinical onset of steatohepatitis;

Note: Alcohol consumption is calculated utilising the Australian Standard of 10 grams of alcohol per standard alcoholic drink.

(9)for females, consuming at least 30 kilograms of alcohol within any 5 year period before the clinical onset of steatohepatitis;

Note: Alcohol consumption is calculated utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink.

(10)having hyperuricaemia at the time of the clinical onset of steatohepatitis;

Note: hyperuricaemia is defined in the Schedule 1 – Dictionary.

(11)taking irinotecan for at least the 30 days before the clinical onset of steatohepatitis;

(12)taking a drug specified in the Schedule 2 - Drugs of this Instrument, that cannot be ceased or substituted, for at least the 30 days before the clinical onset of steatohepatitis;

(13)taking a drug that cannot be ceased or substituted and which is associated in the individual with:

(a)the development of steatohepatitis within 30 days of first taking the drug; and

(b)the redevelopment of steatohepatitis on rechallenge with the same drug;

(14)inability to obtain appropriate clinical management for steatohepatitis.

  1. Relationship to service

(1)The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person.

(2)The factor set out in subsection 9(14) applies only to material contribution to, or aggravation of, steatohepatitis where the person's steatohepatitis was suffered or contracted before or during (but did not arise out of) the person's relevant service.

  1. Factors referring to an injury or disease covered by another Statement of Principles

In this Statement of Principles:

(1)if a factor referred to in section 9 applies in relation to a person; and

(2)that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(2) of the VEA;

then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.

Schedule 1 - Dictionary

Note: See Section 6

  1. Definitions

In this instrument:

being obese means:

(a)having a Body Mass Index (BMI) of 30 or greater; or

(b)for males, having a waist circumference exceeding 102 centimetres; or

(c)for females, having a waist circumference exceeding 88 centimetres.

Note: BMI is also defined in the Schedule 1 - Dictionary.

BMI means W/H2 where:

(a)W is the person's weight in kilograms; and

(b)H is the person's height in metres.

dyslipidaemia means persistently abnormal blood lipid levels, diagnosed by a medical practitioner and evidenced by:

(a)a serum high density lipoprotein cholesterol level less than 1.0 mmol/L; or

(b)a serum low density lipoprotein cholesterol level greater than 4.0 mmol/L; or

(c)a serum triglyceride level greater than or equal to 2.0 mmol/L; or

(d)a total serum cholesterol level greater than 5.5 mmol/L; or

(e)the regular administration of drug therapy to normalise blood lipid levels.

hyperuricaemia means a serum uric acid level of at least 0.40 mmo/L.

MRCAmeans the Military Rehabilitation and Compensation Act 2004.

rapid weight loss means reduction of body mass by at least 20 percent, within a continuous period of no more than 6 months.

Note: Situations which can be associated with rapid weight loss and protein-calorie malnutrition include anorexia nervosa, acute starvation and surgery causing significant diarrhoea or malabsorption (for example, extensive small bowel resection and pancreaticoduodenectomy).

relevant service means:

(a)operational service under the VEA;

(b)peacekeeping service under the VEA;

(c)hazardous service under the VEA;

(d)British nuclear test defence service under the VEA;

(e)warlike service under the MRCA; or

(f)non-warlike service under the MRCA.

Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary.

steatohepatitis—see subsection 7(2).

terminal event means the proximate or ultimate cause of death and includes the following:

(a) pneumonia;

(b) respiratory failure;

(c) cardiac arrest;

(d) circulatory failure; or

(e) cessation of brain function.

total parenteral nutrition means a total nutrient admixture providing calories, amino acids, electrolytes, fluids, minerals, trace elements and vitamins, by the intravenous route.

VEA means the Veterans' Entitlements Act 1986.


Schedule 2 - Drugs

Note:  See Section 6, Subsection 9(12)

  1. Specified drugs

1.     amiodarone 2.     antiretroviral agents 3.     asparaginase
4.     beta-blockers 5.     calcium channel blockers 6.     carbamazepine
7.     cisplatin 8.     diethylamino-ethyoxyhexestrol 9.     diethylstilbestrol
10.     estrogen 11.     fialuridine 12.     fluorouracil
13.     glucocorticoids 14.     linezolid 15.     methotrexate
16.     oxaliplatin 17.     pegaspargase 18.     perhexiline
19.     raloxifene 20.     rifampicin 21.     tamoxifen
22.     tetracycline antibiotics 23.     tianeptine 24.     toremifene
25.     troglitazone 26.     valproate
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